Lioresal 5mg/5ml Oral solution

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Baclofen

Inapatikana kutoka:

Novartis Ireland Limited

ATC kanuni:

M03BX; M03BX01

INN (Jina la Kimataifa):

Baclofen

Kipimo:

5 mg/5ml

Dawa fomu:

Oral solution

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Other centrally acting agents; baclofen

Idhini hali ya:

Marketed

Idhini ya tarehe:

1984-04-18

Taarifa za kipeperushi

PACKAGE LEAFLET : INFORMATION FOR THE PATIENT
LIORESAL® 5 MG/5 ML
ORAL SOLUTION
(BACLOFEN)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it
onto others. It may harm them even if
their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not
listed in this leaflet..
WHAT IS IN THIS LEAFLET
1. What Lioresal is and what it is used for
2. What you need to know beforeyou take Lioresal
3. How to take Lioresal
4. Possible side effects
5. How to store Lioresal
6. Contents of the pack and other information.
1. WHAT LIORESAL IS AND WHAT IT IS USED FOR
1. WHAT LIORESAL IS AND WHAT IT IS USED FOR
Lioresal contains the active ingredient, baclofen.
Baclofen is a muscle-relaxant drug.
Lioresal is used to relieve muscle rigidity (spasticity) or spasms in
adults and children, which may occur
as a result of illnesses such as cerebral palsy, multiple sclerosis,
cerebrovascular accidents, spinal cord
diseases and other nervous system disorders.
22. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIORESAL
. BEFORE YOU TAKE LIORESAL 2. BEFORE YOU TAKE LIORESAL
Do not take Lioresal if:
• you are allergic (hypersensitive) to baclofen or any of the other
ingredients of Lioresal (listed in Section
6)
•Do not take Lioresal if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking
Lioresal.
TAKE SPECIAL CARE
Check with your doctor or pharmacist before taking your medicine if:
• you have epilepsy
• you have a mental illness such as schizophrenia, psychosis,
depressive or manic disorders or
confusional states
• you have high blood pressure
• you have Parkinson’s disease
• you have any liver, kidney or lung disease
• you have diabetes
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Tabia za bidhaa

Health Products Regulatory Authority
28 January 2022
CRN00CS45
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lioresal 5mg/5ml Oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution contains 1 mg/1 ml baclofen.
Excipients with known effect:
methyl parahydroxybenzoate 1.4mg per ml
propyl parahydroxybenzoate 0.14mg per ml
sodium 1.62 mg per ml
sorbitol 385mg per ml
benzyl alcohol 0.01mg per ml
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
A clear, colourless to faintly yellowish slightly viscous solution.
Odour of raspberries.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lioresal is indicated for the relief of spasticity of voluntary muscle
resulting from such disorders as: multiple sclerosis, other
spinal lesions, e.g. syringomyelia, motor neurone disease, transverse
myelitis.
Lioresal is also indicated in adults for the relief of spasticity of
voluntary muscle arising from e.g. cerebrovascular accidents,
cerebral palsy, meningitis, traumatic head injury.
Patient selection is important when initiating Lioresal therapy; it is
likely to be of most benefit in patients whose spasticity
constitutes a handicap to activities and/or physiotherapy. Treatment
should not be commenced until the spastic state has
become stabilised.
Paediatric population
Baclofen is indicated in patients below 18 years for the symptomatic
treatment of spasticity of cerebral origin, especially where
due to infantile cerebral palsy, as well as following cerebrovascular
accidents or in the presence of neoplastic or degenerative
brain disease.
Baclofen is also indicated for the symptomatic treatment of muscle
spasms occurring in spinal cord diseases of infectious,
degenerative, traumatic, neoplastic, or unknown origin such as
multiple sclerosis, spastic spinal paralysis, amyotrophic lateral
sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or
paraparesis, and compression of the spinal cord.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lioresal